Genentech will gain joint development and commercialization rights to Roche subsidiary GlycArt's humanized anti-CD20 monoclonal antibody GA101 for the potential treatment of hematological malignancies and other cancers under a deal announced Oct. 2.

GlycArt is owned by Roche, Genentech's majority stakeholder, so the deal includes all three partners. Apparently, Roche and Genentech still have time to collaborate despite having yet to hash out a suitable takeover price. Roche has owned GlycArt since 2005, when it acquired the Swiss biotech for $182 million.

Under the deal, all three partners will share certain development costs. Genentech will lead regulatory filings in the U.S. and gain U.S. commercialization rights. As a result, the company will record a $105 million research and development expense in the third quarter.

GA101 is an enhanced humanized anti-CD20 antibody in Phase I/II clinical trials for CD20-positive B-cell malignancies, such as non-Hodgkin's lymphoma and chronic lymphocytic leukemia. Its high-powered engineering means it could work in patients who currently don't respond to treatment.

"We believe GA101 has the potential to extend the therapeutic benefit over current standards of care, including treatment for patients who do not respond to current therapies," GlycArt said in a statement.

Genentech is plenty experienced in anti-CD20 antibodies. The company markets Rituxan (rituximab), partnered with Biogen Idec and approved for non-Hodgkin's lymphoma and rheumatoid arthritis. But not all patients respond to Rituxan, which means there still is opportunity for enhanced antibodies.

Genentech and Biogen already are doing their own work on next-generation drugs. The companies have two next-generation anti-CD20s in development. The first is in Phase III for rheumatoid arthritis and Phase II for multiple sclerosis; a program in lupus was halted after Rituxan disappointed in the disease in a Phase II/III trial (¹ Also see "Rituxan For Lupus Misses Primary, Secondary Endpoints" - Pink Sheet, 29 April, 2008.). A third-generation anti-CD20 is in earlier development, in Phase I for CLL and NHL.

Anti-CD20 antibodies bind to CD20 antigens on the surface of B-cells, then recruit the body's natural defenses to attack and kill the antibody-bound B cells. GlycArt's proprietary GlycoMab glycosylation technology increases the potency of therapeutic antibodies targeting malignant cells by engineering the carbohydrate component present in the antibodies. Specifically, it increases antibody-dependent cellular cytotoxicity (ADCC), the process that ultimately destroys the cells to which an antibody is bound.

Other antibody developers are using their own optimization technologies to create similarly enhanced antibodies. Among them are Xencor, BioWa and GlycoFi, which was acquired by Merck in 2006 (² Also see "Merck’s Biotech Pipeline Gets A Boost From Two Acquisitions" - Pink Sheet, 9 May, 2006.). These firms also are focused on strengthening ADCC function, albeit through different technologies.

Genentech already inked a deal with Xencor in 2004 to license its Xmab technology to develop next-generation antibodies against CD20 and HER2 by optimizing Rituxan and Herceptin .

-Jessica Merrill (j.merrill@elsevier.com)

Genentech Takes Over GlycArt Anti-CD20 Antibody Work

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